Ayala Pharmaceuticals Inc (ADXS)

[huskercatman123]

https://patents.justia.com/patent/8956621

Here is an excerpt:


Safety and Efficacy of LM-LLO-E7 for the Treatment of Cervical Intraepithelial Neoplasia

Advaxis has treated 45 patients with grade 2 or 3 Cervical Intraepithelial Neoplasia (cervical dysplasia) thus far in a trial designed to treat 120 patents. Three treatment groups of 40 patients each are comprised of 10 patients who get placebo on a randomized basis and 30 patients who get active drug at 5.107, 3.3×108 or 1×109 cfu. A safety run in of 3 patients is conducted for each dosage group and these patients receive the active drug. The remaining 37 patients are randomized to either placebo or active drug at a ratio of 3 active patients for each placebo patient. The trial involves the administration of Advaxis agent ADXS11-001 directed against HPV 16-E7 3 times at 28 day intervals followed by a surgical LEEP procedure 6 months after the initial dose. Pretreatment biopsy samples are compared with post treatment LEEP surgery specimens for an assessment of histologic response.

The objective of this study was to see whether a vaccine regimen can replace surgery. Aside from the pain, bleeding, and other aspects of surgery, the removal of a portion of the cervix often leads to an inability to come to a full term pregnancy (“incompetent cervix”). A pharmaceutical treatment would thus be preferential to surgery. Especially one that induces immunologic memory against the etiologic agent that causes cervix cancer, HPV, in a manner that protects against recurrence.

At the present time the random code has not been broken, however of the 18 treated patients 3-4 patients have receive placebo and 14-15 patients have received active drug. The average spontaneous remission rate in this population is approximately 25%, and 4-5 patients spontaneously remit assuming the experimental agent was ineffective, but in the 18 patients treated to date, irrespective of treatment, 14 have remitted. Thus, a therapeutic effect of the agent on the precancerous condition of CIN is being observed.